The FDA approves Intersect ENT Inc.'s second steroid-releasing product, Propel mini. According to a press release from Intersect ENT, the approval will help patients suffering from chronic sinusitis benefit from localized drug delivery.
The Propel mometasone furoate implant, approved last year by the FDA, is a spring-like implant that is inserted by a physician following endoscopic sinus surgery. The implant expands to prop open the sinus, gradually delivers an advanced steroid with anti-inflammatory properties directly to the sinus lining, then dissolves into the body. The result is improved surgical outcomes, reducing the need for additional surgical procedures and for systemic steroids, which can have serious side effects.
"Propel has been recognized as a revolutionary advancement in the treatment of chronic sinusitis from both a technological and a clinical perspective,” says Dr. Joseph Jacobs, Professor and Director of Rhinology at NYU Langone Medical Center, New York City, New York. “Clinical studies have clearly demonstrated that localized drug delivery offers significant advantages for patients undergoing endoscopic sinus surgery. My surgical patients have benefited from the addition of Propel to their care, and I am pleased that I will soon be able to offer this innovative treatment to a broader range of my patients.
Intersect ENT initiated sales of Propel in limited regions of the country over the past year. Propel mini will be offered in select hospitals starting this month and will be launched nationwide in conjunction with a planned sales force expansion in 2013.